WASHINGTON -- Before recessing for Thanksgiving,congressional lawmakers introduced a bill adding restrictionsto the Orphan Drug Act and sent legislation to President Bushextending biotechnology-related tax credits that would haveexpired on Dec. 31.

Senators Nancy Kassebaum, R-Kan., and Howard Metzenbaum,D-Ohio, introduced the Orphan Drug Amendments of 1991 towithdraw orphan drug protection from drugs with more than$200 million in sales.

The amendments would allow companies to appeal withdrawalof orphan status if they can demonstrate that highdevelopment costs justify the revenues, and would requirewithdrawal of orphan status at the point in a three-yearprojection where the patient population for approvedtreatment exceeds 200,000.

The bill also would continue the Orphan Drug Act of 1983 forthree more years, extend authorization of the research grantprogram, and replace the existing Orphan Drugs Products Boardwith an Office of Orphan Drugs.

Kassebaum called the law a success, noting that 469 drugs havereceived orphan designation and 59 of those have beenapproved for marketing. But she said the amendments areneeded to "restore the credibility of the Orphan Drug Act."

Some manufacturers have used orphan status to "shieldthemselves from competition," Kassebaum charged, citing"extremely high prices" for erythropoietin, a treatment foranemia associated with chronic renal failure, and humangrowth hormone, a treatment for pituitary dwarfism.

"These are not drugs of 'limited commercial viability' whichneeded the incentives offered by the Orphan Drug Act to assuretheir development," Kassebaum said. However, she added that"as a practical matter, the overwhelming majority of orphandrugs will never have sales even approaching $200 millionover a seven-year period."

Kassebaum has called for hearings on the bill early next year,but no date has been set, said spokesman Mike Horak.

"The White House opposes the bill, and I expect that they willmake that publicly known very shortly," said Lisa Raines, vicepresident for governmental relations for the IndustrialBiotechnology Association.

"This bill is significantly more onerous than the orphan drugbill that the president vetoed last year," she said. "But I doubtit will get that far."

Raines said she expects Bush to sign the bill extending to June30, 1992, the research and experimentation tax credit, a 20percent credit for qualified research expenditures, and theorphan drug tax credit, a 50 percent tax credit for clinicaltesting of orphan drugs.

-- Kris Herbst BioWorld Washington Bureau

(c) 1997 American Health Consultants. All rights reserved.